Migration Issues/ Questions about Migrated Protocols

***Start reading from the bottom. New items will be added to the top of this list.

Q.5. During our training you mentioned that non-BUMC staff or investigators not having access to INSPIR listed on a protocol would be migrated to a separate section in INSPIR II. I can’t seem to find those people on protocol H-12345. I can only view names for those having access to INSPIR. All others, even some BU staff on the protocol are not listed. Can you direct me to the section where I may find these names?

A.5. You are right. People who were listed on the protocol in INSPIR 1 as non-BUMC staff or BUMC staff without access to INSPIR were migrated over to INSPIR but will appear in a different section of the application. There are two ways to locate these people:

Open up the protocol. From the study management page- click onto the study “application”. From the Section by Section view (left hand column) look for the section that says KSP INFORMATION. (Carolina – for your study H-23320 it is Section #4.0 but it may be a different section number for other people based on what information was migrated.) When you open this section you will see all the “investigators” listed in INSPIR I with all their contact information, the COI section etc.

Open up the protocol. From the study management page- click onto the study “application”. Once the study opens- click on ENTIRE VIEW OF APPLICATION and scroll down. You will eventually come to the KSP information section where all investigators will be listed.

Remember: Investigators and study staff “migrated over” as non-BUMC staff or BUMC staff without access to INSPIR will NOT be able to log into INSPIR II and see the study (or consent forms, etc.) until

They obtain a BU user-name and Kerberos password (if they don’t already have one)

You submit an Change Internal Investigator amendment to (officially) add them to the protocol - directions for how to do this are posted on the IRB website

Q.4. We would like to respond to board request for corrections and/or additions to H-12345, [migrated over from INSPIR I] but we are unable to see a memo telling us what needs to be addressed. We can open the Review Response Submission Form.

A.4. Since Letters (mod memos) from INSPIR I migrated as PDFs you cannot directly respond to them like you used to. You will need to copy the contents of the letter and then paste the contents into the section 4.0 Response comments when you click on the Text Editor. Here you can respond in color or italics to differentiate from the questions.

Q.3. For the sections that state “read only” info will be migrated over from INSPIR I. What if I am trying to add a brand new protocol – how do I complete those sections?

A.3. Do nothing for those sections for new protocols. Those are just “placeholder” sections for data from migrated studies. Just skip these questions for new studies.

Q.2.:I now have access to more protocols than before. Am I correct in thinking that INSPIR II gives me access to every protocol that includes me as co-investigator/study personnel?

A.2. Yes, INSPIR access gives you access to every protocol that includes you as a co-investigator or study personnel (or any “role” in the study). Department Chairs will be able to see all studies on which they are listed as the Department Chair.

Q.1.Is there some easy way to identify amendments and progress reports that are awaiting IRB approval? In other words, is there something equivalent to the old “Pending” category? I am waiting on 1 amendment (H-28858) and one PR (H-22466) but don’t see any info on those unless I know to open the protocol.

A.1. From your homepage, when you click on “my studies” you will see a listing of ALL studies associated with you.

Filter: You can “filter” the studies to see only approved, exempts, pending, etc. by clicking on “filter my studies by study status” button at the top of the page (instead of the default button which displays all studies and lists them by most recently used).

Sort: You may also Click on individual columns headers (e.g. principal investigator) and then click on “A-Z” to sort studies by PI A-Z or Z to A.